The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer

Not yet recruiting

• Conditions: Breast Edema; Breast Lymphedema; Lymphedema, Breast Cancer; Lymphedema

• Registration Number: NCT06900023
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this observational study is to learn if participants agree to take part in the study, if the methods we are using for the study are feasible for the participants and the researchers, and to study how well two tools (tissue dielectric constant and ultrasound) measure breast edema after breast conserving surgery for breast cancer.

Participants who agree to be in the study will be asked to come in for one appointment of approximately two hours. All data will be collected during this one visit. Participants will be asked to fill out two questionnaires regarding their symptoms, and one questionnaire regarding their surgical scar. The research staff will conduct a clinical examination, measure breast edema using ultrasound and tissue dielectric constant, measure arm volume with the perometer and fluid with the SOZO, and take photographs of both breasts.

Detailed Description

The goal of this observational study is to learn if the study protocol is feasible, if we can accrue participants easily, and to determine how well two tools (tissue dielectric constant and ultrasound) identify breast edema after breast conserving surgery for breast cancer.

Participants will be asked to attend one appointment in which all data will be collected. This will include questionnaires regarding symptoms, clinical examination, measurement of breast edema using two tools (ultrasound and tissue dielectric constant), measurement with the perometer and SOZO, and clinical photographs.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-02-25
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue Dielectric Constant	Baseline	A TDC interbreast ratio ≥ 1.28 in any quadrant will be used as an indicator of breast lymphedema
Breast Ultrasound	Baseline	Skin thickness \>1.60 mm in superior and lateral quadrants, \>2.0 mm in the medial and inferior quadrants will be used as an indicator of breast lymphedema.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcome Measures	Baseline	Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales vi. Satisfaction with Information - Breast Surgeon (min score 12, max score 48), higher score indicating better outcome
Scar Assessment Tool	Baseline	Patient and Observer Scar Scale Linear Scar Version 3.0
Clinical Examination of Lymphedema of the Upper Extremity Clinical Exam Tool	Baseline	This is a validated measure used to administer clinical examination of the breast, trunk and upper extremity for lymphedema
Clinical Examination - Pitting Edema	Baseline	The following will be assessed: * Each breast quadrant: Presence or absence of pitting edema; * The participant is placed in supine. The examiner's thumb is placed firmly on the participant's skin, applying sustained pressure to the skin and superficial tissue for one minute. Upon release of the pressure, an indentation of the tissue at the test site is defined as pitting and is recorded as Yes in the relevant quadrant. If there is no change in the tissue, record No to pitting oedema.
Clinical Examination - Peau d'orange	Baseline	The following will be assessed: * Each breast quadrant, lateral chest wall and inframammary tissues: Presence or absence of peau d'orange; * The participant is positioned sitting. The examiner slightly compresses the breast tissue between their first finger and thumb to look for the orange peel appearance to the skin. A light can be shone tangentially across the breast to assist in identifying peau d'orange.
Clinical Examination - Erythema	Baseline	The following will be assessed: - Each breast quadrant: Presence or absence of erythema (redness of the skin)
Clinical Examination - Scar localization	Baseline	The following will be assessed: - Scar measurements for the breast and axillary scars, including location (quadrant, distance from the center of the nipple to the center of the scar), scar length, width and orientation (vertical, horizontal, oblique or radial).
Clinical Examination - Visual fullness	Baseline	The following will be assessed: - Lateral chest wall and inframammary tissue: The examiner will record presence or absence of visual fullness
Clinical Examination - Tissue thickening	Baseline	The following will be assessed by the examiner: - Nipple and nipple-areolar complex: Tissue thickening on the side of surgery as compared to the unaffected side
Clinical Examination - Tissue fibrosis	Baseline	The following will be assessed: * Each breast quadrant: Presence or absence of tissue fibrosis; * The participant is placed in supine. The examiner uses their first finger and thumb to palpate the tissue and gently pinch the tissue to assess for any tissue thickening, increased firmness or density and/or tissue retraction or fixation, compared to the equivalent tissue on the unaffected side. If the participant has had surgery on the unaffected breast (e.g. breast reduction), the tissue in the quadrant most distal to the incision site is used as the comparator tissue. N/A is marked in the table for the unaffected breast, unless the participant has had surgery on the unaffected side and tissue fibrosis is detected as a result compared to other quadrants of the unaffected breast.
Clinical Examination - Tenderness to palpation	Baseline	The following will be assessed: * Each breast quadrant: Presence or absence of tenderness to palpation.; * The examiner will lightly palpate the tissue of each breast quadrant to see if the participant reports any pain or tenderness. Deep palpation, particularly medially in the breast, may cause tenderness in the costochondral cartilages.
Clinical Examination - Stemmer sign	Baseline	The following will be assessed: - Lateral chest wall and inframammary tissue: Presence or absence of the Stemmer sign. The Stemmer sign is a physical examination finding used to diagnose lymphedema. If the examiner cannot pinch the skin then this positive finding is associated with lymphedema. The Stemmer sign has been found to be a sensitive predictor for primary and secondary lymphedema with moderate specificity (Goss JA, Greene AK. Sensitivity and Specificity of the Stemmer Sign for Lymphedema: A Clinical Lymphoscintigraphic Study. Plast Reconstr Surg Glob Open. 2019 Jun 25;7(6):e2295. doi: 10.1097/GOX.0000000000002295. PMID: 31624689; PMCID: PMC6635205)
Clinical Examination - Skin color changes	Baseline	The following will be assessed by the examiner: - Nipple and nipple-areolar complex: Skin color changes as compared to the unaffected side (lighter, darker, same)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States